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Sign in to claim this brandWhat C O S M E D SRL makes
The company produces cardiopulmonary stress exercise monitoring systems for assessing cardiovascular and respiratory function during exercise testing, as well as professional diagnostic spirometers for measuring lung function. Their portfolio also includes cardiac stress exercise monitoring systems for evaluating heart performance under controlled workloads and indirect calorimeters for analyzing metabolic rate and energy expenditure.
These devices are classified as Class II under regulatory frameworks, with several listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable medical device regulations for diagnostic and monitoring equipment.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Cosmed Srl manufacture?
Cosmed Srl specializes in devices used for assessing cardiovascular and respiratory health. Their portfolio includes cardiopulmonary stress exercise monitoring systems, which evaluate heart and lung function during exercise testing, as well as professional diagnostic spirometers for measuring lung capacity. They also produce cardiac stress exercise monitoring systems to assess heart performance under controlled conditions and indirect calorimeters to analyze metabolic rate and energy expenditure.
Where is Cosmed Srl based, and what regulatory region does it operate in?
Cosmed Srl is based in the United States. As a manufacturer, it develops devices that comply with applicable U.S. medical device regulations, ensuring their products meet the necessary standards for diagnostic and monitoring equipment in that region.
Which regulatory registries or databases list Cosmed Srl’s devices?
Several of Cosmed Srl’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability in the healthcare system.
How are Cosmed Srl’s devices classified under regulatory frameworks?
Cosmed Srl’s devices fall under Class II classification in regulatory frameworks. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness, such as those used for diagnostic testing and monitoring of cardiovascular and respiratory function.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- cosmed.it
- —
- —
- [email protected]
- Phone
- +39069315492
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 438896136
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cosmed | K4b2 | FDA UDI | Class II | Active |
| Cosmed | Fitmate Pro | FDA UDI | Class II | Active |
| Cosmed | Spiropalm | FDA UDI | Class II | Active |
| Cosmed | Spiropalm 6MWT | FDA UDI | Class II | Active |
| Cosmed | Quark C12x | FDA UDI | Class II | Active |
| Cosmed | Quark T12x | FDA UDI | Class II | Active |
| Cosmed | Pony FX MIP/MEP | FDA UDI | Class II | Active |
| Cosmed | K5 | FDA UDI | Class II | Active |
| Cosmed | Pony FX Flowsafe | FDA UDI | Class II | Active |
| Cosmed | Fitmate Med | FDA UDI | Class II | Active |
| Cosmed | Fitmate GS | FDA UDI | Class II | Active |
| Cosmed | Fitmate | FDA UDI | Class II | Active |
| Cosmed | K4b2 | FDA UDI | Class II | Active |
| Cosmed | Pony FX | FDA UDI | Class II | Active |
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